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VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579591
Recruitment Status : Unknown
Verified April 2012 by Vincenzo Valentini, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : April 18, 2012
Last Update Posted : April 18, 2012
Information provided by (Responsible Party):
Vincenzo Valentini, Catholic University of the Sacred Heart

Brief Summary:
This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent CT and pelvic RT.

Condition or disease Intervention/treatment Phase
Rectal Cancer Other: VSL#3 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in Increasing the Pathological Major Response Rate in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy
Study Start Date : March 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : June 2013

Arm Intervention/treatment
1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.

Placebo Comparator: Placebo Other: Placebo
1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards

Primary Outcome Measures :
  1. The impact of the probiotic preparation on increasing the TRG1-2 rate. [ Time Frame: From the date of randomization until to the date of surgery, up to 18 weeks ]

Secondary Outcome Measures :
  1. Determine whether VSL#3® can have an impact on reduction of acute bowel toxicity [ Time Frame: 12-36 months ]
  2. pathological complete response (pCR) [ Time Frame: 12-36 months ]
  3. impact on reduction of sphincter saving surgery (SSS) [ Time Frame: 12-36 months ]
  4. disease free survival (DFS) at 36 months [ Time Frame: 36 months ]
  5. Determine whether VSL#3® can have an impact on reduction of late toxicity at 12 and 36 months. [ Time Frame: 12, 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Ability to sign informed consent and understand the nature of a placebo- controlled trial.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Life expectancy ≥ 6 months.
  • Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam RT to the pelvis to a minimum dose of 4500 cGy delivered with conventional multi-field photon radiotherapy, 3-D conformal photon radiotherapy or intensity modulated photon therapy.
  • Will receive concurrent administration of chemotherapy (5-FU, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin) during pelvic RT
  • The following laboratory values obtained > 28 days prior to registration:

Hemoglobin > 10.0 g/dL WBC > 3,500 Absolute neutrophil count > 1,500 Platelets > 100,000

  • ECOG Performance Status (PS) of 0, 1 or 2
  • Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment.

Exclusion Criteria:

  • Current or prior metastases beyond regional lymph nodes.
  • Undergone abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum.
  • Known allergy to a probiotic preparation.
  • Any history of inflammatory bowel disease.

    -> grade 3 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool, ≤7 days prior to registration.

  • Any medical condition that may interfere with ability to receive protocol treatment.
  • Planned use of leucovorin (because of the risk of secretory diarrhea).
  • Split-course RT is planned.
  • Prior pelvic RT.
  • Proton RT.
  • Any of the following:

Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception

  • Use of probiotics ≤ 2 weeks prior to registration.
  • Use of antibiotics ≤ 1 week prior to registration.
  • Planned continuous antibiotic treatment during RT.
  • History of gastrointestinal or genitourinary obstruction or porphyria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01579591

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Contact: Vincenzo Valentini, MD +390630155226

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Catholic University of Sacred Heart- Rome- Recruiting
Rome, Italy, 00168
Contact: Vincenzo Valentini, MD    +390630155226   
Principal Investigator: Vincenzo Valentini, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

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Responsible Party: Vincenzo Valentini, Associated professor, Catholic University of the Sacred Heart Identifier: NCT01579591     History of Changes
Other Study ID Numbers: A.1459/2011
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: April 18, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases